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Influenza ModRNA Vaccine

Phase 2

Influenza, Human | Monoclonal antibody | Infectious Disease |Pfizer, Inc.|Last Updated: Jan 9, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment1,202
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06436703A Study About Modified RNA Vaccines Against Influenza in Healthy AdultsPHASE2 COMPLETED 1,202 — — May 23, 2024Feb 5, 2025Jan 9, 202632 United States
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Study Endpoints
Primary Endpoints
SSA - Percentage of Participants Reporting Local Reactions After Vaccination
From Day 1 Through at least Day 7 After Vaccination

Pain at the injection site, redness, and swelling.

SSA - Percentage of Participants Reporting Systemic Events After Vaccination
From Day 1 Through at least Day 7 After Vaccination

Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain.

SSA - Percentage of Participants Reporting Adverse Events After Vaccination
From Day 1 Through 4 Weeks After Vaccination

As elicited by investigational site staff

SSA - Percentage of Participants Reporting Serious Adverse Events (SAE)
From Day 1 Through 6 Months After Vaccination

As elicited by investigational site staff

SSA - Percentage of Participants Reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs)
From Day 1 Through 6 Months After Vaccination

As elicited by investigational site staff

SSA - Percentage of Participants Reporting Medically Attended AEs (MAEs)
From Day 1 Through 6 Months After Vaccination

As elicited by investigational site staff

SSB - Percentage of Participants Reporting Local Reactions After Vaccination
From Day 1 Through at least Day 7 After Vaccination

Pain at injection site, redness, and swelling.

SSB - Percentage of Participants Reporting Systemic Events After Vaccination
From Day 1 Through at least Day 7 After Vaccination

Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain.

SSB - Percentage of Participants Reporting Adverse Events After Vaccination
From Day 1 Through 4 Weeks After Vaccination

As elicited by investigational site staff

SSB - Percentage of Participants Reporting Serious Adverse Events (SAE)
From Day 1 Through 6 Months After Vaccination

As elicited by investigational site staff

SSB - Percentage of Participants Reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs)
From Day 1 Through 6 Months After Vaccination

As elicited by investigational site staff

SSB - Percentage of Participants Reporting Medically Attended AEs (MAEs)
From Day 1 Through 6 Months After Vaccination

As elicited by investigational site staff

SSC - Percentage of Participants Reporting Local Reactions After Vaccination
From Day 1 Through at least Day 7 After Vaccination

Pain at the injection site, redness, and swelling.

SSC - Percentage of Participants Reporting Systemic Events After Vaccination
From Day 1 Through at least Day 7 After Vaccination

Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain.

SSC - Percentage of Participants Reporting Adverse Events After Vaccination
From Day 1 Through 4 Weeks After Vaccination

As elicited by investigational site staff

SSC - Percentage of Participants Reporting Serious Adverse Events (SAE)
From Day 1 Through 6 Months After Vaccination

As elicited by investigational site staff

SSC - Percentage of Participants Reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs)
From Day 1 Through 6 Months After Vaccination

As elicited by investigational site staff

SSC - Percentage of Participants Reporting Medically Attended AEs (MAEs)
From Day 1 Through 6 Months After Vaccination

As elicited by investigational site staff

Secondary Endpoints
SSA - HAI Geometric Mean Titers (GMTs) for each strain
4 Weeks After Vaccination
SSA - HAI geometric mean fold rise (GMFR) for each strain
4 Weeks After Vaccination
SSA - The proportion of participants achieving HAI seroconversion for each strain
4 Weeks After Vaccination
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
SSA: Influenza ModRNA Vaccine 2AEXPERIMENTAL\- Single Dose on Day 1
SSA: Influenza ModRNA Vaccine 3AEXPERIMENTAL\- Single Dose on Day 1
SSA: Influenza ModRNA Vaccine 4AEXPERIMENTAL\- Single Dose on Day 1
SSA: Influenza ModRNA Vaccine 5AEXPERIMENTAL\- Single dose on Day 1
SSA: QIV1ACTIVE_COMPARATOR\- Single dose on Day 1
SSB: Influenza ModRNA Vaccine 3BEXPERIMENTAL\- Single Dose on Day 1
SSB: Influenza ModRNA Vaccine 4BEXPERIMENTAL\- Single Dose on Day 1
SSB: Influenza ModRNA Vaccine 5BEXPERIMENTAL\- Single dose on Day 1
SSB: QIV2ACTIVE_COMPARATOR\- Single Dose on Day 1
SSB: QIV3ACTIVE_COMPARATOR\- Single Dose on Day 1
SSC: Influenza ModRNA Vaccine 3CEXPERIMENTAL\- Single Dose on Day 1
SSC: Influenza ModRNA Vaccine 4CEXPERIMENTAL\- Single Dose on Day 1
SSC: Influenza ModRNA Vaccine 5CEXPERIMENTAL\- Single Dose on Day 1
SSC: Influenza ModRNA Vaccine 6CEXPERIMENTAL\- Single Dose on Day 1
SSC: Influenza ModRNA Vaccine 7CEXPERIMENTAL\- Single Dose on Day 1
SSC: Influenza ModRNA Vaccine 8CEXPERIMENTAL\- Single Dose on Day 1
SSC: Influenza ModRNA Vaccine 9CEXPERIMENTAL\- Single dose on Day 1
SSC: QIV2ACTIVE_COMPARATOR\- Single Dose on Day 1
SSC: QIV3ACTIVE_COMPARATOR\- Single Dose on Day 1
Interventions
NameTypeDescription
Influenza ModRNA VaccineBIOLOGICALIntramuscular injection
Quadrivalent Influenza Vaccine (QIV)BIOLOGICALIntramuscular injection
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites32

Key Inclusion Criteria Applies to all 3 substudies: * participants ≥18 years of age. * generally healthy participants. Substudy C ONLY: \- receipt of licensed influenza vaccination for the 2023-2024 flu season at least 6 months ago. Key Exclusion Criteria All 3 substudies: * diagnosis of infl...

Countries:United States
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